KIMGUARD* ONE-STEP* Sterlization Wrap (KC100, KC200, KC300 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Non-Lumen Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed PSD-85 Sterilization Cycles.

The PSD-85 Lumen Cycle has been validated to sterilize a load of up to ten (10) pounds (combined pouch and wrapped tray load) containing a maximum of ten (10) single channel stainless steel lumens per load with the following dimensions:

· An inside diameter of 1 mm or larger and a length of 60 mm or shorter;
An inside diameter of 2 mm or larger and a length of 250 mm or shorter;

· An inside diameter of 3 mm or larger and a length of 350 mm or shorter.

The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load).

All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC300, KC400, KC500, and KC600) have been validated for use with the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer cycles in Table 1.

Device Description

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of antistatic treatment. The wrap allows a sterilized package to be opened aseptically.

AI/ML Overview

This document is a 510(k) premarket notification for KIMGUARD* ONE-STEP* Sterilization Wrap. It asserts substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Sterilant Penetration	Passed
Material Compatibility/Biocompatibility (post-sterilization)	Passed
Performance Testing (Post-Sterilization)	Passed
Maintenance of Package Integrity (180 Days)	Passed
Allows sterilization of enclosed medical devices by Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (Lumen and Non-Lumen Cycles)	Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps allowed sterilization of the enclosed devices by the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer.
Allows effective aeration under pre-programmed PSD-85 Sterilization Cycles	KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed PSD-85 Sterilization Cycles.
Maintenance of sterility until used	KIMGUARD* ONE-STEP* Sterilization Wrap is intended to allow sterilization and also maintain sterility of the enclosed device(s) until used. Real-time testing following sterilization using Sterilucent PSD-85 Hydrogen Peroxide Sterilizer supports maintenance of package sterility for 180 days.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the testing of the sterilization wrap. It refers to "Test results validated" and "Real-time testing" but does not provide details on the number of units tested.

The data provenance is not specified in terms of country of origin. The studies are nonclinical tests conducted by the manufacturer (Halyard Health, formerly Kimberly-Clark Health Care).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a sterilization wrap, not a diagnostic or AI-driven device requiring expert interpretation for ground truth. The "ground truth" for this type of device is established by objective performance criteria (e.g., microbial ingress, sterility testing, material compatibility) defined by regulatory standards and scientific methodologies, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient data by human readers. The tests performed for this sterilization wrap are objective, nonclinical performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. MRMC studies and AI assistance benefits are relevant to diagnostic devices or software that aid human interpretation. This document pertains to a physical sterilization wrap.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This refers to a medical device in the form of a physical sterilization wrap, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance of the sterilization wrap is established through various objective nonclinical tests based on recognized standards and methodologies. These include:

Microbiological testing: To assess sterilant penetration and maintenance of sterility (e.g., bacterial challenge tests, sterility assurance level (SAL)).
Physical and material property testing: To evaluate material compatibility, integrity, and aeration properties.
Real-time shelf-life studies: To confirm the duration for which sterility is maintained.

The document explicitly states that testing was done "in accordance with the applicable requirements recommended in Pre-Market Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002)." This guidance outlines the scientific methods to establish the "ground truth" for such devices.

8. The sample size for the training set

This information is not applicable. This refers to a manufactured product (sterilization wrap) rather than a machine learning model, so there is no training set in the context of AI.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above; there is no training set for a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18,2014

Halyard Health (Formerly known as Kimberly-Clark Health Care) C/O Mr. Peter Kalkbrenner Sterilucent, Inc. Director of Engineering 1400 Marshall Street, NE Minneapolis, MN 55413

Re: K141712

Trade/Device Name: KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: November 19, 2014 Received: November 20, 2014

Dear Mr. Kalkbrenner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kalkbrenner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K141712

Device Name

KIMGUARD* ONE-STEP* Sterlization Wrap (Models KC100, KC300, KC400, KC500, and KC600)

Indications for Use (Describe)

KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

. Sterilucent PSD-85 Hydrogen Peroxide Sterilizer that include:
- Lumen Cycle and o
- Non-Lumen Cycle. o

· An inside diameter of 1 mm or larger and a length of 60 mm or shorter;
An inside diameter of 2 mm or larger and a length of 250 mm or shorter;

· An inside diameter of 3 mm or larger and a length of 350 mm or shorter.

The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load).

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TABLE 1: Validated Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Cycle(Note: The instructions provided below are not intended to replace the detailed Instructions for Use providedwith the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer.)
PSD-85 Cycle	Intended Loads
Lumen	Reusable metal and nonmetal devices including devices with diffusion-restricted spaces suchas the hinged portion of forceps and scissors and up to 10 single channel stainless steellumened devices of the following dimensions per chamber load:An inside diameter of 1 mm or larger and a length of 60 mm or shorter An inside diameter of 2 mm or larger and a length of 250 mm or shorter An inside diameter of 3 mm or larger and a length of 350 mm or shorter (Refer to the PSD-85 User Manual for complete instructions on load(s) and cycle(s), includingchamber loading instructions (i.e. 10 lbs per load)
Non-Lumen	Non-lumened reusable metal and nonmetal devices including devices with stainless steeldiffusion-restricted spaces such as the hinged portion of forceps and scissors.(Refer to the PSD-85 User Manual for complete instructions on load(s) and cycle(s), includingchamber loading instructions (i.e. 25 lbs per load))

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X | Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant's Name, Address, Telephone, FAX, Contact Person Halyard Health (formerly known as Kimberly-Clark Health Care) 1400 Holcomb Bridge Road Roswell, GA 30076-2190, USA Establishment Registration Number: 1033422 Contact Name: Thomas Kozma, Director of Regulatory Affairs E-mail: thomas.kozma@hyh.com Phone: 770.587.8393 FAX: 920.225.3408 Date Prepared: November 19, 2014 TRADE NAME: KIMGUARD ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600) CLASSIFICATION NAME: Sterilization Wrap Common/Usual Name: Sterilization Wrap FRG Product Code: DEVICE CLASSIFICATION: Class II per 21 CFR §880.6850 Predicate Devices: K112805 - KIMGUARD® ONE-STEP* Sterilization Wrap (Models KC100, KC200, KC300, KC400, KC500, and KC600).

INDICATIONS FOR USE

KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

Sterilucent PSD-85 Hydrogen Peroxide Sterilizer that include: ●
- o Lumen Cycle and
- o Non-Lumen Cycle.

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD ONE-STEP® Sterilization Wraps (KC100, KC200, KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (i.e., both the Lumen and Non-Lumen Cycles). Additionally, the KIMGUARD ONE-STEP® Sterilization Wrap was validated to allow effective aeration under the pre-programmed PSD-85 Sterilization Cycles.

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· An inside diameter of 1 mm or larger and a length of 60 mm or shorter;
An inside diameter of 2 mm or larger and a length of 250 mm or shorter:
An inside diameter of 3 mm or larger and a length of 350 mm or shorter.

The PSD-85 Non-Lumen Cycle has been validated to sterilize a load of up to 25 pounds (combined pouch and wrapped tray load).

All models of the KIMGUARD ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500, and KC600) have been validated for use with the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer cycles in Table 1.

TABLE 1: Validated Sterilucent PSD-85 Hydrogen Peroxide Sterilizer Cycle(Note: The instructions provided below are not intended to replace the detailedInstructions for Use provided with the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer.)
PSD-85 Cycle	Intended Loads
Lumen	Reusable metal and nonmetal devices including devices with diffusion-restrictedspaces such as the hinged portion of forceps and scissors and up to 10 singlechannel stainless steel lumened devices of the following dimensions per chamberload:An inside diameter of 1 mm or larger and a length of 60 mm or shorter An inside diameter of 2 mm or larger and a length of 250 mm or shorter An inside diameter of 3 mm or larger and a length of 350 mm or shorter (Refer to the PSD-85 User Manual for complete instructions on load(s) andcycle(s), including chamber loading instructions (i.e. 10 lbs per load)
Non-Lumen	Non-lumened reusable metal and nonmetal devices including devices withstainless steel diffusion-restricted spaces such as the hinged portion of forcepsand scissors.(Refer to the PSD-85 User Manual for complete instructions on load(s) andcycle(s), including chamber loading instructions (i.e. 25 lbs per load))

DESCRIPTION OF DEVICE

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Substantial Equivalence to Predicate Device

KIMGUARD ONE-STEP* Sterilization Wrap (i.e., subject of this Premarket Notification) is substantially equivalent to the predicate Kimberly-Clark KIMGUARD* ONE-STEP* Sterilization Wraps (K112805) in technology, design, and materials.

The following table compares the subject KIMGUARD* ONE-STEP* Sterilization Wrap to the predicate KIMGUARD* ONE-STEP* Sterilization Wrap.

Characteristics	Predicate Devices:KIMGUARD* ONE-STEP* SterilizationWrap (KC100, KC200, KC300, KC400,KC500, & KC600) (K112805)	Proposed Device:KIMGUARD* ONE-STEP* Sterilization Wrap(KC100, KC200, KC300, KC400, KC500, &KC600)
Manufacturer	Kimberly-Clark Corporation	Kimberly Clark Corporation [SAME]
Regulation/ProductCode	Sterilization Wrap: 880.6850 / FRG	Sterilization Wrap: 880.6850 / FRG[SAME]
Indications for Use	The device is intended to be used to encloseanother medical device that is to be sterilized by ahealthcare provider by the Amsco® V-PRO™ 1Plus Low Temperature Sterilization System'sLumen (identical to the V-PRO™ 1 Cycle) andNon-Lumen Cycles, and the V-PRO™ LowTemperature Sterilization System's Flexible Cycle.The wrap is intended to allow sterilization of theenclosed medical device(s) and also to maintainsterility of the enclosed device(s) until openedwithin the period of time for which performancedata demonstrating maintenance of sterility hasbeen provided. The KIMIGUARD ONE-STEP*Sterilization Wrap was validated to be effectivelyaerated during the pre-programmed V-PRO™, V-PRO™ 1 Plus, and V-PRO™ Flexible Cycles.	KIMGUARD* ONE-STEP* Sterilization Wrap(KC100, KC200, KC300, KC400, KC500 andKC600) are intended to enclose another medicaldevice that is to be sterilized by a healthcareprovider using:• Sterilucent PSD-85 Hydrogen PeroxideSterilizer that includes:• Lumen Cycle• Non-Lumen CycleKIMGUARD* ONE-STEP* Sterilization Wrap(KC100, KC200, KC300, KC400, KC500 andKC600) are intended to allow sterilization of theenclosed medical device(s) and also maintainsterility of the enclosed device(s) until used.
SterilizationParameters	Hydrogen Peroxide-based Amsco® V-PRO™1 Plus Low Temperature SterilizationSystem's Lumen (identical to the V-PRO™ 1Cycle) and Non-Lumen Cycles, and the V-PRO™ Low Temperature SterilizationSystem's Flexible Cycle	Sterilucent PSD-85 Hydrogen PeroxideSterilizer that includes:• Lumen Cycle• Non-Lumen Cycle
Maintenance ofPackage Sterility	For models KC100, KC200, KC300, K400,KC500, and KC600 for at least 30 days.	Real-time testing following sterilization usingSterilucent PSD-85 Hydrogen PeroxideSterilizer supports maintenance of packagesterility for 180 days for all models ofKIMGUARD* ONE-STEP* Sterilization Wrap.
Technology	Tortuous sheet material used to enclosemedical devices that are to be sterilized by ahealthcare provider to allow sterilization ofthe enclosed medical device(s) and maintainsterility of the enclosed device(s) until used.	Tortuous sheet material used to enclosemedical devices that are to be sterilized by ahealthcare provider to allow sterilization ofthe enclosed medical device(s) and maintainsterility of the enclosed device(s) until used.[SAME]
Device Design	Two sheets of nonwoven polypropylenefabric. Each sheet is composed of threethermally- bonded layers consisting of aMeltblown polypropylene layer surrounded bySpunbound polypropylene layers (SMS)	Two sheets of nonwoven polypropylenefabric. Each sheet is composed of threethermally- bonded layers consisting of aMeltblown polypropylene layer surroundedby Spunbound polypropylene layers (SMS)[SAME]
Characteristics	Predicate Devices:KIMGUARD* ONE-STEP* SterilizationWrap (KC100, KC200, KC300, KC400,KC500, & KC600) (K112805)	Proposed Device:KIMGUARD* ONE-STEP* Sterilization Wrap(KC100, KC200, KC300, KC400, KC500, &KC600)
Method for bondingSMS layers	Thermal bonding with round pin, hexagonal,triangle bond pattern ("daisy" pattern)	Thermal bonding with round pin, hexagonal,triangle bond pattern ("daisy" pattern)[SAME]
Materials	Polypropylene with blue and whitepigments	Polypropylene with blue and whitepigments[SAME]
Distribution	Non-Sterile andOver-the-Counter	Non-Sterile andOver-the-Counter[SAME]
Single Use Device	Yes	Yes[SAME]

Device Comparison Table (Technological. Design, & Materials)

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SUMMARY OF NONCLINICAL TESTS

Performance of KIMGUARD* ONE-STEP* Sterilization Wrap (KC100. KC200. KC300, KC400. KC500, KC600) has been tested in accordance with the applicable requirements recommended in Pre-Market Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDA (March 7, 2002). All results of testing met acceptance criteria demonstrating that the KIMGUARD* ONE-STEP* Sterilization Wrap allows sterilization of contents by Sterilucent PSD-85 Hydrogen Peroxide Sterilizer and maintains sterility of contents until used.

Summary of Testing Performed	Results
Sterilucent System Sterilant Penetration	Passed
Material Compatibility/Biocompatibility - post-sterilization(Cytotoxicity- ISO Elution, ISO Intracutaneous Reactivity,ISO guinea Pig Maximization Sensitization)	Passed
Performance Testing - Post-Sterilization	Passed
Maintenance of Package Integrity (180 Days)	Passed

OVERALL PERFORMANCE CONCLUSIONS

The nonclinical studies demonstrate that the KIMGUARD* ONE-STEP* Sterilization Wrap performs as intended as a sterilization packaging system of medical devices when terminally sterilized in the Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (Lumen and Non-Lumen Cycles). These studies demonstrate that the KIMGUARD* ONE-STEP* Sterilization Wrap met the same criteria as the predicate devices and are substantially equivalent.

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).